DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Amendment
1) Acknowledgment is made of Applicants’ amendment filed 02/11/26 in response to the non-final Office Action mailed 08/13/25.
Status of Claims
2) Claims 1, 12 and 23 have been amended via the amendment filed 02/11/26.
Claim 13 has been canceled via the amendment filed 02/11/26.
New claim 129 has been added via the amendment filed 02/11/26.
Claims 1, 8, 10-12, 22, 23, 26, 27, 61, 72-76, 93, 104, 109, 110 and 129 are pending.
The examination has been extended to the previously non-elected SERPIN peptide species comprising therein SEQ ID NO: 41.
Claims 1, 8, 10, 11, 23, 26, 110 and 129 are under examination.
Information Disclosure Statement
3) Acknowledgment is made of Applicants’ information disclosure statement filed 02/11/26. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Prior Citation of Title 35 Sections
4) The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office Action References.
Prior Citation of References
5) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Withdrawn
6) The objection to the specification set forth at paragraph 9(b) of the Office Action mailed 08/13/25 is withdrawn in light of Applicants’ amendment to the specification.
Objection(s) Maintained
7) The objection to the specification set forth at paragraph 9(a) of the Office Action mailed 08/13/25 is maintained. The as-filed specification continues to include trademark recitations. For example, see section [0091] for “Alexa Fluor-488”. All trademark recitations should be CAPITALIZED wherever they appear, or where appropriate, should include a proper symbol indicating use in commerce such as TM, SM, or ® following the term. See M.P.E.P 608.01(v) and Appendix l. Although the use of trademarks is permissible in patent applications, the propriety nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. It is suggested that Applicants examine the whole specification to make similar corrections to trademark recitations, wherever such recitations appear.
Rejection(s) Moot
8) The rejection of claim 13 set forth at paragraph 11 of the Office Action mailed 08/13/25 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is moot in light of Applicants’ cancellation of the claim.
Rejection(s) Withdrawn
9) The rejection of claim 1 set forth at paragraph 11 of the Office Action mailed 08/13/25 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicants’ claim amendments.
10) The rejection of claims 1 and 110 set forth at paragraph 11(b) of the Office Action mailed 08/13/25 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn.
Applicants refer to MPEP § 2173.02 and state that a decision on whether a claim is indefinite under 35 U.S.C § 112(b) or pre-AIA 35 U.S.C 112, second paragraph requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of the specification. Applicants refer to line 27 of page 6 to line 25 of page 7, lines 4-11 of page 9, and the paragraph bridging pages 9 and 10 and contend that reducing inflammation is an objective in the treatment of the recited inflammatory diseases and the reduction can be identified, for example, using methods described in the specification such as identifying a reduction in symptoms of inflammation, reduction in inflammatory cell recruitment, reduction in inflammatory markers in bronchoalveolar lavage fluid, or reduction in Clinical Dermatitis score (e.g. for dermatitis) among others.
11) The rejection of claims 8, 10, 11, 23, 26 and 110 set forth at paragraph 11(c) of the Office Action mailed 08/13/25 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in light of Applicants’ amendments to the base claim.
12) The rejection of claims 1, 8, 10, 11 and 110 set forth at paragraph 13 of the Office Action mailed 08/13/25 under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by WO 2017/040287 (WO ‘287, of record) is withdrawn in light of Applicants’ claim amendments.
13) The rejection of claims 1, 8, 10, 11 and 110 set forth at paragraph 13 of the Office Action mailed 08/13/25 under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by Toldo et al. (JACC Basic Transl. Sci. 2(5): 561-574, 2017, of record) as evidenced by Wohlford et al. (PLOS ONE 16(5): e0247357, pages 1/1 to 1/11, 06 May 2021, of record) is withdrawn in light of Applicants’ claim amendments.
14) The rejection of claims 1, 8, 10, 11, 26 and 110 set forth at paragraph 16 of the Office Action mailed 08/13/25 on the ground of non-statutory obviousness double patenting as being unpatentable over claims 1-12 of US 11020462 B2 (of record) is withdrawn in light of Applicants’ amendments to the base claim.
Rejection(s) Maintained
15) The rejection of claims 1, 8, 10, 11, 26 and 110 set forth at paragraph 17 of the Office Action mailed 08/13/25 on the ground of non-statutory obviousness double patenting as being unpatentable over claims 1-12 of US 11779630 B2 (of record) is maintained.
Applicants request that the rejection be held in abeyance until the claims are otherwise in condition for allowance.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First Paragraph
16) The following is a quotation of 35 U.S.C § 112(a):
(a) IN GENERAL. - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out the invention.
17) Claims 1, 8, 10, 11, 23, 26, 110 and 129 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicants have demonstrated possession of the full scope of the claimed invention at the time of the invention. A review of the instant specification indicates the following.
The independent claim 1 is representative of the claimed invention. Claim 1 is drawn to a method of reducing inflammation in a subject having a disease or condition associated with LRP1 or TSLP, the elected species being dermatitis or atopic dermatitis, an effective amount of a SERPIN peptide comprising SEQ ID NO: 35, the elected species, or a SERPIN peptide comprising SEQ ID NO: 41, the species to which the examination is being extended to. The administration encompasses topical, oral, and parenteral administration. Said method is required to reduce eosinophilic inflammation and reduce inflammation in a subject having a disease or condition associated with LRP1 or TSLP including dermatitis or atopic dermatitis. However, at the time of the invention, Applicants were not in possession of a method as claimed wherein administering of a SERPIN peptide comprising SEQ ID NO: 41 by the topical, oral, and parenteral route to a subject having a disease or condition associated with LRP1 or TSLP such as dermatitis or atopic dermatitis reduces eosinophilic inflammation and reduces inflammation in said subject.
The written description inquiry is case- and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. According to MPEP 2163:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. In the instant application, this is important because the as-filed specification establishes functional unpredictability with regard to SERPIN peptides. For example, the as-filed specification shows that the SP16 short core peptide SEQ ID NO: 20, despite containing what is described as ‘the LRP1 binding site’ (shown in bold and underlining in Table 1) VKFNKPFVFLM, and despite having the capacity of reducing NFkB activity, failed to exhibit an inflammation-inhibiting effect. See the last two sentences of section [0100], Table 1, and the first two sentences of section [0102] of the as-filed specification. Further, section [0103] of the as-filed specification states that when the LRP1 binding site in the SRP peptide was truncated, to obtain SP31, VRFNRPFL, not only its anti-inflammatory activity was lost, but the anti-inflammatory activity could not be restored with the polyarginine flanks, SP32 peptide, RRRVRFNRPFLRRR. See bottom two rows of Table 1. This is important because the currently examined SERPIN peptide species RFNRPFLVVIR (SEQ ID NO: 41) comprises therein the LRP1 site FNRPFL (shown via bold underlining at the bottom of Table 1) similar to the SP32 peptide with no anti-inflammatory activity. There is no evidence in the as-filed specification correlating the structure a SERPIN peptide comprising therein SEQ ID NO: 41 with the requisite inflammation-reducing therapeutic effects or functions in any subject having a disease or condition associated with LRP1 or TSLP including dermatitis or atopic dermatitis. Based on the above-identified disclosure in Applicants’ as-filed specification, there is no predictability that if one administered, by any route, a SERPIN peptide comprising therein the FNRPFL-containing SEQ ID NO: 41 to any subject having a disease or condition associated with LRP1 or TSLP including dermatitis or atopic dermatitis, said administration would exert inflammation-reducing therapeutic effects and eosinophilic inflammation-reducing effects in said subject. The required structure-function correlation for the administered SEQ ID NO: 41 is lacking. Note that for inventions in emerging and/or unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1980) holds that an adequate written description requires ‘not a mere wish or plan for obtaining the claimed ……. invention.’ In the instant case, a concrete structure-function for the administered SERPIN peptide comprising SEQ ID NO: 41 is lacking. Clearly, Applicants did not describe the invention of the instant claims sufficiently to show that they had possession of the full scope of the method as claimed at the time of the invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph.
Double Patenting Rejection(s)
18) Claims 1, 8, 10, 11, 23, 26, 110 and 129 are provisionally rejected ground of non-statutory obviousness double patenting as being unpatentable over claims 12, 1, 2, 8-11, 22, 23 and 26 of the co-pending application 18726945. Although the claims at issue are not identical, they are not patentably distinct from each other. Said claims of the co-pending ‘945 application, drawn to a method of reducing inflammation in a human subject having a disease or condition associated with LRP1 or TSLP such as dermatitis or atopic dermatitis comprising administering orally, topically, intranasally, transdermally, intradermally or parenterally a dose of a SERPIN peptide comprising the VKFNKPFVFL[NIe]IEQNTK, i.e., SEQ ID NO: 35, the dose being between 0.001 mg/kg to 5 mg/kg, read on and anticipate instant claims. Reduction in eosinophilic inflammation is an inherent characteristic intrinsic to the administered SEQ ID NO: 35.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
19) No claims are allowed.
The dependent claim 110 is objected to for having an antecedence issue with regard to the limitation “administering”. For proper antecedence, it is suggested that Applicants replace the limitation “administering the” with the limitation --the administering of the--.
20) Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
21) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
22) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
April, 2026
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